Ignite Creation Date:
2024-05-06 @ 1:23 PM
Last Modification Date:
2024-10-26 @ 1:13 PM
Study NCT ID:
NCT04005053
Status:
COMPLETED
Last Update Posted:
2023-08-15
First Post:
2019-06-27
Brief Title:
Signatures of N-Ac for Non-Suicidal Self-Injury in Adolescents
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Identifying Biological Signatures of N-Acetylcysteine for Non-Suicidal Self-Injury in Adolescents and Young Adults
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To measure NAC-induced changes to concentrations of glutathione GSH in the anterior cingulate cortex ACC as measured by magnetic resonance spectroscopy MRS in 36 adolescents and young adults with NSSI 12 in each group high low and placebo
Detailed Description:
This study is a double-blind placebo controlled 4-week course of two-tiered N-acetylcysteine NAC dosing focused on identifying the optimal dose to achieve meaningful change in measurable biomarkers glutathione and glutamate
This design will allow us to confirm acute biological changes select the optimal dose for achieving biological effects and examine doseconcentration-response relationships with respect to biological markers and pharmacokinetics
Brief schedule of activities Subjects will be recruited through community and clinical settings and screened over the phone There will be a total of 4 in-person visits and two sets of on-line study activities
Eligible participants will be assigned to one of 3 groups double-blinded a low-dose NAC group 3600 mgday a high-dose NAC group 5400mgday and placebo PBO The study intervention period is 4 weeks Total participation is up to 8 weeks depending on the length of time between Day 0 and Day 1
The investigators will recruit 36 adolescents and young adults aged 16-24 years There will be 12 participants in each group PBO 3600mgday 5400mgday The investigators will use a minimization procedure to ensure that the participants in these 3 groups will have similar age clinical severity and medication status
This design will allow us to confirm acute biological changes select the optimal dose for achieving biological effects and examine doseconcentration-response relationships with respect to biological markers and pharmacokinetics
Brief schedule of activities Subjects will be recruited through community and clinical settings and screened over the phone There will be a total of 4 in-person visits and two sets of on-line study activities
Eligible participants will be assigned to one of 3 groups double-blinded a low-dose NAC group 3600 mgday a high-dose NAC group 5400mgday and placebo PBO The study intervention period is 4 weeks Total participation is up to 8 weeks depending on the length of time between Day 0 and Day 1
The investigators will recruit 36 adolescents and young adults aged 16-24 years There will be 12 participants in each group PBO 3600mgday 5400mgday The investigators will use a minimization procedure to ensure that the participants in these 3 groups will have similar age clinical severity and medication status
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None